更新于：2024-12-26
Invariant Natural Killer T Cells(Beijing YouAn Hospital)
更新于：2024-12-26
概要
基本信息
非在研机构- |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)临床2期 |
特殊审评- |
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关联
3
项与 Invariant Natural Killer T Cells(Beijing YouAn Hospital) 相关的临床试验Study of lenvatinib combined with iNKT cell immunotherapy for advanced hepatocellular carcinoma
开始日期2022-01-05 |
申办/合作机构- |
Study of Adoptive Transfer of Invariant Natural Killer T Cells Combined With TAE/TACE to Treat Unresectable Hepatocellular Carcinoma (HCC): Phase II Clinical Trial
Hepatocellular carcinoma (HCC) is a common disease with high mortality. More than 80% patients receive a diagnosis when their tumors are too advanced for curative approaches and have a dismal prognosis. invariant Natural Killer T (iNKT) cell exhibit antitumor activity against malignant tumors through producing high levels of cytokines. iNKT cells are abundant in the liver, but their function is defective in liver cancer. After expansion and restored function in vitro, iNKT cells can home to liver, then they play key antitumor function. We have finished a phase I study of adoptive transfer of autologous iNKT cells for treating patients with unresectable HCC. Safety and feasibility of iNKT infusion was proved. The purpose of this study was to verify the effectiveness of iNKT cell infusion in patients with unresectable HCC who had previously failed transcatheter arterial embolization (TAE) / transcatheter arterial chemoembolization (TACE).
开始日期2018-03-01 |
申办/合作机构 |
A Study of Adoptive Invariant Nature Killer T Cell Therapy for Relapsed/Advanced Hepatocellular Carcinoma (HCC)
This study enrolls patients who have relapsed/advanced hepatocellular carcinoma (HCC, BCLC stage C). The HCC tumor relapsed or metastasized through the body after standard treatment or the patients cannot receive standard treatment under current conditions. This research study uses special immune system cells called iNKT cells, a new experimental treatment.
The purpose of this study is to find the biggest dose of iNKT cells that is safe and tolerance, to see how long they last in the body, to learn the immunoresponse in the body, to learn the side effects are and to see if the iNKT cells will help people with relapsed/advanced hepatocellular carcinoma (HCC).
The purpose of this study is to find the biggest dose of iNKT cells that is safe and tolerance, to see how long they last in the body, to learn the immunoresponse in the body, to learn the side effects are and to see if the iNKT cells will help people with relapsed/advanced hepatocellular carcinoma (HCC).
开始日期2017-04-01 |
100 项与 Invariant Natural Killer T Cells(Beijing YouAn Hospital) 相关的临床结果
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100 项与 Invariant Natural Killer T Cells(Beijing YouAn Hospital) 相关的转化医学
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100 项与 Invariant Natural Killer T Cells(Beijing YouAn Hospital) 相关的专利（医药）
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2
项与 Invariant Natural Killer T Cells(Beijing YouAn Hospital) 相关的文献（医药）2024-09-01·INFLAMMATION RESEARCH
Alpha-galactosylceramide pre-treatment attenuates clinical symptoms of LPS-induced acute neuroinflammation by converting pathogenic iNKT cells to anti-inflammatory iNKT10 cells in the brain
Article
作者: Lee, Sung Won ; Kim, Tae-Cheol ; Van Kaer, Luc ; Hong, Seokmann ; Park, Yun Hoo ; Park, Hyun Jung
BACKGROUND:
Invariant natural killer T (iNKT) cells play protective or pathogenic roles in a variety of immune and inflammatory diseases. However, whether iNKT cells contribute to the progression of acute neuroinflammation remains unclear. Thus, we addressed this question with a mouse model of lipopolysaccharide (LPS)-induced acute neuroinflammation.
METHODS:
For induction of acute neuroinflammation, wild-type (WT) C57BL/6 (B6) mice were injected intraperitoneally (i.p.) with LPS for either three or five consecutive days, and then these mice were analyzed for brain-infiltrating leukocytes or mouse behaviors, respectively. To examine the role of iNKT cell activation in LPS-induced neuroinflammation, mice were injected i.p. with the iNKT cell agonist α-galactosylceramide (α-GalCer) seven days prior to LPS treatment. Immune cells infiltrated into the brain during LPS-induced neuroinflammation were determined by flow cytometry. In addition, LPS-induced clinical behavior symptoms such as depressive-like behavior and memory impairment in mice were evaluated by the open field and Y-maze tests, respectively.
RESULTS:
We found that iNKT cell-deficient Jα18 mutant mice display delayed disease progression and decreased leukocyte infiltration into the brain compared with WT mice, indicating that iNKT cells contribute to the pathogenesis of LPS-induced neuroinflammation. Since it has been reported that pre-treatment with α-GalCer, an iNKT cell agonist, can convert iNKT cells towards anti-inflammatory phenotypes, we next explored whether pre-activation of iNKT cells with α-GalCer can regulate LPS-induced neuroinflammation. Strikingly, we found that α-GalCer pre-treatment significantly delays the onset of clinical symptoms, including depression-like behavior and memory impairment, while decreasing brain infiltration of pro-inflammatory natural killer cells and neutrophils, in this model of LPS-induced neuroinflammation. Such anti-inflammatory effects of α-GalCer pre-treatment closely correlated with iNKT cell polarization towards IL4- and IL10-producing phenotypes. Furthermore, α-GalCer pre-treatment restored the expression of suppressive markers on brain regulatory T cells during LPS-induced neuroinflammation.
CONCLUSION:
Our findings provide strong evidence that α-GalCer-induced pre-activation of iNKT cells expands iNKT10 cells, mitigating depressive-like behaviors and brain infiltration of inflammatory immune cells induced by LPS-induced acute neuroinflammation. Thus, we suggest the prophylactic potential of iNKT cells and α-GalCer against acute neuroinflammation.
JOURNAL OF MEDICINAL CHEMISTRY
Enhancing COVID-19 Vaccine Efficacy: Dual Adjuvant Strategies with TLR7/8 Agonists and Glycolipids
Article
作者: Li, Ke ; Jin, Hui ; Luo, Rui ; Liu, Zheng ; Tu, Xin-Yi ; Hu, Xing ; Huang, Ting ; Huang, Lei-Lei ; Xian, Mao-Ying
The controlled release of immunostimulatory agents represents a promising strategy to enhance vaccine efficacy while minimizing side effects. This study aimed to improve the efficacy of the RBD-Fc-based COVID-19 vaccine through combining of an iNKT cell agonist and a TLR7/8 agonist using covalent conjugation and temporal delivery. We hypothesized that these combinations would yield a more balanced Th1/Th2 immune response. For covalent conjugation, we employed an uncleavable linker and a self-immolative disulfide linker to conjugate α-galactosylceramide (αGC) to imidazoquinoline (IMDQ). The αGC-SS-IMDQ-Ac conjugate, designed with a prodrug strategy for controlled TLR7/8 agonist release, elicited a higher IFN-γ/IL-4 T cell response ratio than individual adjuvants or their admixture. In the temporal delivery approach, administering IMDQ followed by αGC after 2 h resulted in the highest IgG2a/IgG1 ratio, significantly surpassing other groups. A 6 h delay between glycolipid and IMDQ injections yielded balanced IgG responses, enhancing IgG, IgG1, and IgG2a levels synergistically.
5
项与 Invariant Natural Killer T Cells(Beijing YouAn Hospital) 相关的新闻（医药）2023-10-10
CHICAGO, Oct. 10, 2023 /PRNewswire/ -- Signifying a monumental step forward in the domain of powered antibody therapies, the SparX Group is thrilled to unveil its strategic alliance with Arovella Therapeutics Ltd (ASX: ALA). This collaboration emphasizes the utilization of SPX-101, an innovative monoclonal antibody (mAb) that targets the Claudin 18.2 (CLDN18.2) tumor specific antigen, as an exciting component in Arovella's CLDN18.2-CAR-iNKT cells as a leading off-the-shelf CAR-iNKT cell therapy.
Dr. Gui-Dong Zhu, CEO of the SparX Group, elucidated on the significance of this collaboration: "Our partnership with Arovella represents a transformative phase in advancing mAb-based therapies. Invariant Natural Killer T (iNKT) cells, distinguished by their recognition of lipid antigens via the CD1d molecule, have emerged as potent therapeutic vectors. Arovella's cutting-edge CAR-iNKT platform, encapsulating advanced techniques for in-vitro expansion and post-infusion persistence of iNKT cells, underscores their leadership in this domain. We profoundly acknowledge CLDN 18.2-iNKT cell therapy as a groundbreaking paradigm in oncological therapeutics."
Echoing the enthusiasm, Dr. Michael Baker, CEO of Arovella, remarked, "Licensing the CLDN18.2 mAb sequence from SparX represents a seminal phase in our therapeutic trajectory. SparX's sophisticated work, spotlighting the unparalleled attributes of their CLDN18.2 monoclonal antibody, coupled with its safety and specificity, accentuates the global attention this molecular target is garnering. We're uniquely positioned as the only global entity developing a CAR-iNKT cell therapy aimed at CLDN18.2. The synergistic combination of iNKT cells with the CLDN18.2 CAR paves an exciting avenue to develop novel cancer therapeutics."
CLDN18.2 manifests predominantly in gastric cancers (GC), gastroesophageal junction cancers (GEJC), pancreatic cancers (PC), and a spectrum of other solid tumors. Both GC and GEJC represent formidable clinical challenges, registering over a million new cases annually worldwide and culminating in 770,000 fatalities. This places them as the fourth leading cause of cancer-related deaths globally. Spearheaded by SparX, SPX-101 embodies a pinnacle of molecular engineering, stemming from SparX's sophisticated SAILINGTM discovery platform. This mAb is designed for optimized therapeutic efficacy, offering the potential to be recognized as a best-in-class molecular entity targeting claudin 18.2.
Expounding on the cellular dynamics, Invariant Natural Killer T (iNKT) cells are a specialized T cell subset known for recognizing lipid antigens via the CD1d molecule. These cells possess inherent attributes like tissue infiltration capabilities, counteracting tumor-promoting cells such as myeloid-derived suppressor cells (MDSCs) and tumor-associated macrophages (TAMs), and orchestrating a robust immune response by recruiting auxiliary immune cells against tumor sites. The pathological architecture of tumor development often exposes the CLDN18.2, rendering it accessible to novel treatments such as CAR-iNKT cell therapies. Preliminary clinical findings indicate that iNKT cell therapies might proffer a superior safety profile relative to alternative T cell therapies, notably displaying a reduced propensity for cytokine release syndrome, a prevalent and potential adverse reaction observed in certain cell therapies.
About SparX Biopharmaceutical:
A research-driven, development-stage biopharmaceutical trailblazer, SparX Biopharmaceutical Corp. has a mission of "amplifying human immunity with groundbreaking antibody therapies." Through the utilization of big data analytics, including machine learning, SparX decrypts potential interactions within the vast complexity of biological information. With meticulous pharmacological analyses, backed by in vitro and in vivo evaluations using advanced mouse models, SparX is on a relentless quest to develop unparalleled or superior therapeutics. SparX's robust target discovery platform, combined with the multifaceted SAILING™ antibody optimization system and groundbreaking bi-ADC technology, is poised to redefine the success metrics of empowered antibody drug development. Equipped with in-house cGMP facilities, SparX is on track to become a self-sustaining, fully integrated biopharmaceutical entity.
SOURCE SparX Group
细胞疗法免疫疗法抗体药物偶联物
2023-09-27
NEW YORK, Sept. 27, 2023 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic, off-the-shelf, invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases, today announced plans to unveil updated clinical and translational data, along with insights on agenT-797’s distinct mechanism of action in solid tumors. A poster will be presented at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting on November 1-5, 2023.
Presentation Details
Title: Peripheral and tissue persistence of agenT-797, an allogeneic iNKT cell-based cell therapy for the treatment of cancer
Presenting Author: Marco Purbhoo, Ph.D., Head of Translational Research, MiNK Therapeutics
Abstract Number: 735
About MiNK Therapeutics
MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases. MiNK is advancing a pipeline of both native and next generation engineered iNKT programs, with a platform designed to facilitate scalable and reproducible manufacturing for off-the-shelf delivery. The company is headquartered in New York, NY. For more information, visit and our Twitter handle @MiNK_iNKT. Information that may be important to investors will be routinely posted on our website and Twitter.
Investor Contact
917-362-1370
investor@minktherapeutics.com
Media Contact
781-674-4428
communications@minktherapeutics.com
细胞疗法免疫疗法AACR会议
2023-08-10
- Randomized Phase 2 Trial in 2L Metastatic Gastric Cancer Planned to Launch at Memorial Sloan Kettering Cancer Center
- iNKT (agenT-797) Data Presented at AACR, ASGCT, and ATS Showed Benefit in Solid Tumor Cancers and in Respiratory Distress
- MiNK-215, a Novel FAP-CAR-iNKT Cell Therapy, Eliminated Tumors in NSCLC Models
NEW YORK, Aug. 10, 2023 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic, off-the-shelf, invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases, today provided a corporate update and reported financial results for the second quarter 2023.
“We made significant clinical progress with our lead compound, agenT-797, an allogeneic iNKT therapy, showing persistence and clinical benefit in patients with solid tumor cancers,” said Chief Executive Officer and President at MiNK, Jennifer Buell, Ph.D. “We will expand on this progress with the launch of our externally funded randomized phase 2 trial in 2L gastric cancer and plan to provide meaningful updates across our clinical programs, manufacturing, and business later this year.”
Company Updates
During Q2, MiNK announced the planned launch of a randomized Phase 2 trial in 2L gastric cancer, led by Dr. Yelena Janjigian, Chief of Gastrointestinal Oncology at Memorial Sloan Kettering Cancer Center. The trial is planned to be fully externally funded and expected to accrue quickly with an anticipated launch in early 3Q2023.
Trial will expand upon data presented at the American Association for Cancer Research (AACR) Annual Meeting showing the clinical benefit of allogeneic iNKTs (agenT-797) with and without anti-PD-1 in multiple solid tumor cancers that had previously failed standard of care therapies, including pembrolizumab and nivolumab. These include responses and durable disease stabilization in patients with gastric cancer, NSCLC, testicular cancer, and beyond.
AgenT-797 was administered without toxic lymphodepletion and was well tolerated in doses up to one billion cells.
Preclinical data presented at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting showed MiNK-215, a fibroblast activation protein (FAP) CAR-iNKT therapeutic candidate, exhibits robust therapeutic activity in non-small cell lung cancer models, resulting in substantial tumor elimination and improved survival compared to T cells alone.
In preclinical models, MiNK-215 increased the killing capacity of partially exhausted T cells, targeted and eliminated tumor promoting FAP-expressing CAFs, and enhanced immune cell infiltration and T cell activation.
IND enabling studies are underway; IND filing on track for 2024.
Data at the American Thoracic Society (ATS) International Conference demonstrated the tolerable safety pro survival benefit of iNKT cells in respiratory distress. In patients with COVID-19 associated acute respiratory distress syndrome (ARDS) on mechanical lung support, those treated with agenT-797 had a 75% survival compared to 30% seen with in-hospital controls.
AgenT-797 showed notable improvement in lung function and significantly reduced inflammation and secondary infections in patients treated. AgenT-797 was dosed to one billion cells with a tolerable safety profile, without oxygenation failure.
MiNK also plans to advance agenT-797 in patients with viral ARDS through an externally funded platform trial.
Financial Results
We ended the second quarter 2023 with a cash balance of $10.6 million as compared to $14.9 million in March 31, 2023, and $19.6 million at December 31, 2022. Cash used in operations for the three-months ended June 30, 2023, was $4.1 million, compared to $4.4 million for the three-months ended March 31, 2023 and $4.6 million for the quarter ended June 30, 2022,
Net loss for the six-months ended June 30, 2023 was $11.9 million, or $0.35 per share, compared to net loss for the same period in 2022 of $13.9 million or $0.41 per share.
Summary Consolidated Financial Information
Condensed Consolidated Balance Sheet Data
(in thousands)
(unaudited)
June 30, 2023
December 31, 2022
Cash and cash equivalents
$
10,622
$
19,636
Total assets
12,112
21,472
Other Financial Information
(in thousands)
(unaudited)
Three months ended June 30,
Six months ended June 30,
2023
2022
2023
2022
Cash used in operations
$
4,151
$
4,626
$
8,517
$
8,822
Non-cash operating expenses
$
950
$
829
1,917
1,642
Condensed Consolidated Statements of Operations Data
(in thousands, except per share data)
(unaudited)
Three months ended June 30,
Six months ended June 30,
2023
2022
2023
2022
Operating expenses:
Research and development
4,558
5,876
8,752
11,154
General and administrative
1,785
1,822
3,445
3,919
Operating loss
6,343
7,698
12,197
15,073
Other income, net
(146
)
(1,585
)
(314
)
(1,183
)
Net loss
$
6,197
$
6,113
$
11,883
$
13,890
Per common share data, basic and diluted:
Net loss
$
(0.18
)
$
(0.18
)
$
(0.35
)
$
(0.41
)
Weighted average number of common shares outstanding, basic and diluted
34,409
33,619
34,189
33,562
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the therapeutic and curative potential of agenT-797, MiNK-215, and iNKT cells, mechanism of action, potency and safety, interim or top-line data, including statements regarding preclinical data of MiNK-215, the anticipated benefits of agenT-797 and MiNK-215, and clinical development plans and timelines. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These forward-looking statements are subject to risks and uncertainties, including the factors described under the Risk Factors section of the most recent Form 10-K, Form 10-Q and the S-1 Registration Statement filed with the SEC. MiNK cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and MiNK undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
About MiNK Therapeutics
MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases. MiNK is advancing a pipeline of both native and next-generation engineered iNKT programs, with a platform designed to facilitate scalable and reproducible manufacturing for off-the-shelf delivery. The company is headquartered in New York, NY. For more information, visit . Follow us on Twitter @MiNK_iNKT.
Investor Contact
917-362-1370
investor@minktherapeutics.com
Media Contact
781-674-4428
communications@minktherapeutics.com
细胞疗法临床结果临床2期AACR会议财报
100 项与 Invariant Natural Killer T Cells(Beijing YouAn Hospital) 相关的药物交易
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 不可切除的肝细胞癌 | 临床2期 | 中国 | 2018-03-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床2期 | 60 | Human recombinated Interleukin-2+iNKT cells (TAE/TACE+iNKT for Unresectable HCC) | 夢艱築鹹壓獵壓憲築糧(醖鑰鏇觸觸獵鑰顧衊顧) = 窪壓鹽窪窪鏇積獵鹽構 願襯夢憲選齋艱壓憲觸 (夢窪艱顧醖遞鏇顧範觸, 夢選膚醖範衊淵遞築淵 ~ 膚膚構糧壓淵齋壓積積) 更多 | - | 2024-10-08 | ||
TACE (TAE/TACE for Unresectable HCC) | 夢艱築鹹壓獵壓憲築糧(醖鑰鏇觸觸獵鑰顧衊顧) = 選積襯膚齋憲蓋願遞膚 願襯夢憲選齋艱壓憲觸 (夢窪艱顧醖遞鏇顧範觸, 鹹夢鹽願獵簾蓋齋選製 ~ 製選簾憲齋壓衊鬱餘簾) 更多 | ||||||
临床1期 | 10 | (iNKT Cell Loading Dose:3x10^7/m2) | 齋壓積憲膚築夢齋蓋鏇(積構糧衊網簾夢鹽獵積) = 範觸製繭製鹹廠積鹽構 鹽艱窪壓餘鬱範蓋蓋衊 (選憲齋願壓積鑰積齋選, 觸糧鏇獵淵範構膚簾顧 ~ 鬱膚鑰範齋積窪鏇衊鹹) 更多 | - | 2024-09-19 | ||
(iNKT Cell Loading Dose:6x10^7/m2) | 齋壓積憲膚築夢齋蓋鏇(積構糧衊網簾夢鹽獵積) = 鑰顧鹽鹹淵膚網鏇製獵 鹽艱窪壓餘鬱範蓋蓋衊 (選憲齋願壓積鑰積齋選, 簾積齋蓋壓壓襯鬱蓋觸 ~ 範繭淵構遞獵顧簾糧鹽) 更多 |
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